AKITA trial bites Guard as weak data force early end to phase 2 open heart surgery study

Guard Therapeutics’ RMC-035 has failed to provide the hoped-for protection in a midphase study. With an interim look at the data suggesting the clinical trial was destined to fail, the Swedish biotech called an early stop to the assessment of the molecule’s ability to prevent kidney injury in heart surgery patients.

Stockholm-based Guard began the phase 2 AKITA study early last year after reviewing the data from four early-phase trials, which suggested RMC-035 is safe and may reduce acute kidney injury (AKI) in people undergoing cardiac surgery. AKI, a common, severe complication of cardiac surgery, is associated with increased morbidity and mortality, creating a need for drugs that protect the kidneys.

RMC-035 now looks unlikely to meet that need. After reviewing data on half of the planned 268 subjects, the independent data monitoring committee recommended stopping the study because it was unlikely to meet its main goals. Guard designed the trial to show whether RMC-035 is better than placebo at preventing AKI in the 72 hours after surgery. 

“We will now analyze the unblinded results and make our own more comprehensive analyses of the study results and then decide upon next steps,” Guard CEO Tobias Agervald said in a statement. Guard is yet to receive the unblinded data.

The phase 2 represented the toughest test yet for RMC-035, Guard’s sole clinical candidate. Guard took the recombinant variant of A1M forward in AKI on the strength of evidence that the endogenous human plasma and tissue protein is a potent antioxidant that protects cells and tissues. The candidate is also in development in kidney transplant patients, a setting in which Guard delivered phase 1b data last month. 

Guard’s share price fell 87% to 0.14 Swedish kroner ($0.01) in trading on the Stockholm stock market in the wake of the news. The drug developer had 201 million kroner ($19 million) in cash and equivalents at the end of last year.